Value from In Vitro Diagnostics

SERODIA® Helps Control Infectious Disease Globally

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The standard for simple, high-quality syphilis test kits

The trend in clinical testing in Japan is toward automation using dedicated machines, which continues to accelerate. However, global trends show that many countries and regions, particularly developing countries, mainly conduct testing manually.
The Treponema Pallidum Hemagglutination (TPHA) kit, which Fujirebio first commercialized successfully in 1966, was recognized as a groundbreaking product for its high reliability and simplicity. Since then, Fujirebio has globally launched various reagents for infectious diseases.
TPHA kit’s successor, SERODIA®, is now widely used as a standard syphilis test kit worldwide. Forty years later, it is still highly regarded globally for its simplicity, which does not require expensive machines, electricity or other infrastructure, and for its accuracy, which prompted its adoption by WHO and the National Institute of Infectious Diseases in Japan.
As a leading manufacturer of test kits for infectious diseases, Fujirebio will keep creating even better products to reduce the number of people suffering from infectious diseases worldwide.

CommentsShipping the gold standard to over 80 countries

SERODIA® is a globally successful test kit that has been shipped to over 80 countries. In addition to its simplicity that requires no special equipment, it is also valued for its stable assay results and ease of handling of the reagents. Listed in the testing guidelines of various countries, it is truly the gold standard of syphilis testing.

Naoaki Tamura
Senior Manager,
Global Sales Section, Global Sales Department,
Fujirebio Inc.

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Innovative Reagent LUMIPULSE® HBsAg-HQ

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Testing reliability with over 10 times more sensitivity

Hepatitis B virus reactivation in patients under chemotherapy or immunosuppressive cancer therapy has become an issue in recent years. Previous testing had speed, cost and sensitivity problems, and a more suitable testing method was medically needed.
However, improving the performance of the conventional approach and techniques was limited. Thus, Fujirebio devised a new development approach. With trial and error, researchers succeeded in developing a reagent over 10 times more sensitive than conventional products ― the LUMIPULSE® HBsAg-HQ. Its enhanced sensitivity has been proven to detect antigens that could not be detected by previous testing, greatly contributing to diagnostic accuracy. It can also quickly provide the results on the same day and at low cost. Its effectiveness has been widely recognized, and is cited in the Japan Society of Hepatology guidelines.
We will continue applying our developmental and technological prowess on testing to help solve societal issues.

CommentsWinning the Japan Society of Clinical Chemistry’s technology award (FY 2017)

The award recognized our technological expertise’s potential contributing to clinical chemistry. Marked by high sensitivity and lower mutation risk, this reagent brought together the Fujirebio Group’s strengths, with the prototype developed at the Advanced Life Science Institute and product development conducted at Fujirebio. Leveraging our experience in developing approaches that widely differ from established concepts, the Group will continue to serve healthcare ― from research to development and production.

Katsumi Aoyagi
Director and Division Head,
Research and Development Divison,
Fujirebio Inc.

LUMIPULSE® HBsAg-HQ Product Development Team
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